Dextrose Concentration Decline Rate in Vivo
- Conditions
- Dextrose Concentration
- Interventions
- Procedure: Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels
- Registration Number
- NCT06128122
- Lead Sponsor
- Dr. Dean Reeves Clinic
- Brief Summary
Measuring the speed of decrease in dextrose concentration to help design more accurate in vitro studies
- Detailed Description
Rationale: In vitro studies of the potential mechanism of action of therapeutic dextrose injection commonly place human or animal cells in a dextrose (glucose) culture medium for a prolonged period of time, typically 24 hours, and expose them to high dextrose levels, typically 1-25% (1000- 25,000mg%). High glucose levels in culture media can cause cell death. Given that cellular apoptosis/death has not been shown to occur after therapeutic dextrose injection in vivo by histologic analysis, we expect that elevated glucose levels drop rapidly in vivo. In this study 12.5% dextrose will be injected intraarticularly (in the knee) and dextrose 5% will be injected subcutaneously, and dextrose level measurements will be obtained at timed intervals after each in order to produce a curve depicting the pattern and speed of decrease in dextrose levels after in vivo injection. In vitro studies can then utilize this information to alter the pattern and speed of decrease of dextrose levels to mimic in vivo conditions, and in so doing provide more useful data on potential mechanisms of therapeutic dextrose injection in soft tissue and joints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1
Able to be relatively immobile for intermittent measurement of dextrose levels
Diabetic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dextrose injection intraarticularly and in subcutaneous tissue with timed dextrose measurements Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels Step One: Injection of 30 ml of D12.5% in the knee anteromedially with knee flexed. Placement of IV catheter into the suprapatellar pouch, and secure catheter. Withdraw and analyze samples for dextrose levels at 15-minute intervals. If catheter fails, aspirate directly from suprapatellar pouch. Step Two: Inject 1-3 ml of D5W into interstitial space about a functioning Dexcom G7 sensor. Measure dextrose levels every 5 minutes on a Dexcom receiver.
- Primary Outcome Measures
Name Time Method Dextrose levels in synovial fluid 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, and 6.0 hours Dextrose level in synovial fluid of the knee, beginning 1/2 hour after intraarticular injection
Dextrose level in subcutaneous tissue (interstitial space) in upper arm or abdomen Continuous glucose measurement Dextrose levels at time zero and every 5 minutes after injection subcutaneously
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kenneth Dean Reeves
🇺🇸Shawnee Mission, Kansas, United States